The announcement follows an MHRA consultation on the future regulation of medical devices in the UK, which asked healthcare professionals and institutions, companies, trade associations and patients for their views on the classification and identification of devices, manufacturers and suppliers.

80% of respondents advocated using GS1 data standards such as GTINs to identify, track and trace medical devices within healthcare supply chains from manufacturing to point of care. As a result, the MHRA will authorize GS1 as the outgoing entity for UDI, supporting the government's strategy to strengthen regulation, improve patient safety and ensure consistency for healthcare manufacturers.

The new MHRA UDI system will be in line with current international regulations and provide a globally harmonized framework for the identification of medical devices. This reduces the risk of clinical error and allows rapid product recall when potentially harmful devices enter the market.

Based on the recommendations of the consultation, the government: Require all medical device manufacturers to assign unique device identifiers, such as GS1 Global Trade Item Numbers (GTINs), to all products. All reusable devices must carry a removable UDI carrier such as a barcode or radio frequency identification (RFID) tag.

Issuing key requirements and guidance for Basic UDI Device Identifiers (BUDI-DI) to ensure that the reason and value of collecting this information is clear.

The government also intends to use data standards to uniquely identify manufacturers, UK responsible persons, importers and distributors, all of whom must register with the MHRA. The consultation offered three options – DUNS, GS1 and the MHRA's own identifier – and more than a third of respondents preferred to use GS1 standards.

The MHRA will work with stakeholders to gradually improve the Act and ensure that its ambitious, transformational reform program enables industry and healthcare providers to adapt to future changes.